 |
Description  |
|
|
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates in general to obstetric devices, and more particular
to devices useful in removing the baby during vaginal delivery.
2. Prior Art
Today's state of the art obstetrics utilizes various procedures to assist
in instances of difficult vaginal deliveries. These procedures basically
fall into three categories: version, Caesarian and forceps assisted
delivery. In the case of severe cephalo-pelvic disproportion, placenta
previa, vaso previa, and other contraindications to vaginal delivery, the
"C-Section," whether classic or low transverse, remains the mainstay
procedure. However, it has long been recognized that to the extent that
C-Section deliveries can be successfully avoided, statistical maternal and
fetal benefits will be realized. Even the non-difficult vaginal delivery
can benefit from non-traumatic assists.
Many problems may develop during delivery which require assistance from the
attending obstetrician to successfully remove the baby from the birth
canal. One such problem results from the presenting part of the baby,
usually its head, descending too slowly. This is particularly true in the
case of the primigravida mother. Even with a completely dilated and
effaced cervix, and an adequate pelvis, a fetus might refuse to descend
beyond station "+1", especially when the mother is suffering from
contraction exhaustion. This can remain a problem even with an assist from
administration of oxytocin (Pitocin). This problem is frequently
exacerbated by anesthesia, particularly in the instance of epidural
anesthesia which frequently produces induced non-beneficial partial atony
of the engaged and dedicated muscles. Such partial atony frequently
results in non-beneficial, and sometimes hazardous, prolongation of labor.
Station "+1" is considered mid-pelvis and in the usual case is considered
too high for a forceps assisted delivery. The risks to the fetus with
forceps application at this level are extreme. Forceps cannot be safely
used until the presenting part is at least at station "+2", and preferably
between stations "+2" and "+3", which is the floor of the perineum.
Modern obstetrics has not developed an alternative to the use of forceps
when an assisted natural delivery is indicated, such as when the fetus is
consistently exhibiting late decelerations of heartbeat following
contractions or is exhibiting non-variability of the baseline heartbeat
rate. Obstetrical forceps are typically, in their various types, two
bladed affairs which are blindly inserted one blade at a time in a
hopefully temporal-cheek position and then articulated together before
assisting traction is applied. Actual traction is exerted slightly below
or underneath the mandible. The traction is point concentrated and
slippage of the forceps is increased because of natural lubrication,
refusal of the fetal skull to conform to existing forceps design, and
other known myriad of variables that vary from one fetus-to-pelvis
physical relationship to another.
Even proper positioning of the forceps can result in harm to the fetus. For
example, in instances of minimal cephalo-pelvic disproportion, the
insertion of one blade of the forceps can exacerbate any slight deficiency
in birth canal adequacy. In addition the softness, or pliability, of the
fetal skull, coupled with the existence of sutures which separate the
plates of the skull, render the skull susceptible to trauma associated
with metal forceps assisted deliveries.
The problems associated with forceps assisted deliveries are well known,
and many attempts have been made to improve forceps design. Examples of
the current state of the art in forceps design can be seen in the
following patents: U.S. Pat. No. 3,550,595 entitled "Obstetrical Forceps"
and issued on Dec. 29, 1970 to Leonard E. Laufe; U.S. Pat. No. 3,605,748
entitled "Obstetrical Forceps" and issued on Sep. 20, 1971 to Hector
Salinas-Benavides; U.S. Pat. No. 3,665,925 entitled "Obstetrical Forceps"
and issued on May 30, 1972 to Hamo M. Dersookian; U.S. Pat. No. 3,785,381
entitled "Pressure Sensing Obstetrical Forceps" and issued on Jan. 15,
1974 to Brenton R. Lower et al; U.S. Pat. No. 3,789,849 entitled
"Obstetrical Forceps" and issued on Feb. 5, 1974 to Leonard E. Laufe et
al; and U.S. Pat. No. 3,794,044 entitled "Delivery Forceps" and issued on
Feb. 26, 1974 to William 0. Vennard.
Despite the long felt need and the large amount of time and effort spent to
develop an alternative to forceps, the only assisting device developed
which has seen some application is a vacuum extractor. Because of the
difficulty in the safe use of this device, it has not proven to be
successful and its use has in large measure been abandoned.
OBJECTS AND SUMMARY OF THE INVENTION
It is therefore an object of this invention to provide an assisting device
for childbirth which can safely perform substantially all of the functions
of forceps.
Another object of this invention is to provide an assisting device for
childbirth that is easy to use and reduces the risk of injury to the fetus
during childbirth.
Still another object of this invention is to provide an assisting device
for childbirth that can be quickly applied to the skull of the fetus by
the attending obstetrician.
Still another object of this invention is to provide an assisting device
for childbirth that can be quickly applied to the lower portion of the
fetus by the attending obstetrician in the case of a breech birth.
Still other objects and advantages of this invention shall become apparent
from the ensuing descriptions of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is cutaway view of an unborn infant positioned for vaginal delivery
to which has been attached one embodiment of this invention.
FIG. 2 is a three dimensional view of one embodiment of this invention.
FIG. 3 is an enlarged view of one embodiment of the closure means forming
part of this invention.
FIG. 4 is an enlarged view of another embodiment of the closure means
forming part of this invention.
FIG. 5 is a three dimensional view of another embodiment of this invention.
FIG. 6A is a three dimensional view of one embodiment of the insertion
means.
FIG. 6B is an enlarged view of the insertion means seen in FIG. 6A.
FIG. 7 is a three dimensional view of one embodiment of this invention
which utilizes the insertion means of FIGS. 6A and 6B.
FIG. 8 is a three dimensional view of the unborn infant to which the
embodiment, as seen in FIG. 7, has been attached.
FIG. 9 is a cut-away view of an unborn infant positioned for vaginal
delivery utilizing another embodiment of the invention.
FIG. 10A is a three dimensional view of on the embodiments of the handle
means of the invention.
FIG. 10B is an enlarged view of the insertion means which can be utilized
with the aforementioned handle means.
FIG. 11 is another three dimensional view of one embodiment of the
invention utilizing the handle means.
FIG. 12 is a three dimensional view of the handle means being utilized to
position one embodiment of the present invention over the head of the
infant.
FIG. 13 is a three dimensional view of the another embodiment of the
present invention attached to the head of the infant.
FIG. 14A depicts a plurality of the insertion means utilized with the
embodiment of FIG. 13.
FIG. 14B is an enlarged view of one of the insertion means as seen in 14A.
FIG. 15 is a three dimensional view of the embodiment depicted in FIG. 13.
FIG. 16 depicts an alternate embodiment of the present invention.
FIG. 17 is another view of the embodiment seen in FIG. 16.
FIG. 18 is a three dimensional view of the embodiment seen in FIG. 17
attached to the head of the infant.
FIG. 19 is a three dimensional view of another embodiment of the invention.
FIG. 20 is a three dimensional view of the preferred embodiment of the
invention.
FIG. 21 is a two dimensional view of the insertion wand member used with
the preferred embodiment illustrated in FIG. 20.
FIG. 22 is an enlarged segment of the angular mesh material of the
preferred embodiment illustrated in FIG. 20.
FIG. 23 is an illustrative view of the preferred embodiment of FIG. 20
being placed about the fetal head.
FIG. 24 is an illustrative view of the preferred embodiment of FIG. 20 as
the device is in traction.
FIG. 25 is a three dimensional view of the preferred embodiment of FIG. 20
that has contained thereon the shrink wrap means.
FIG. 26 is a three dimensional view of an embodiment of the invention being
inserted and positioned to deliver a breech birth.
FIG. 27 is another three dimensional view of the embodiment shown in FIG.
26 being used to deliver a breech birth.
PREFERRED EMBODIMENTS OF THE INVENTION
Like numbers in the various figures refer to like components from the
specification. Referring now to FIG. 1 which depicts one embodiment of the
present invention, a fetus, generally denoted by numeral 1, is depicted
positioned in a cutaway of a portion of a woman's birth canal 2 having the
childbirth assist device 3 attached to its head 4 and trailing outside of
the vagina area of the birth canal 2.
In its broadest context as shown in FIG. 2, the device 3 comprises an
elongated sock-like member 5 open at both ends not only to allow a
physician to fit his hand and arm in passageway 6 of member 5 for
rotational purposes, but also to allow the head 4 to fit into passageway
6. In addition device 3 comprises a collar 7 attached at one end 8 of
member 5 which can be adjusted to restrict the size of opening 9 formed at
end 8.
In one embodiment, member 5 is constructed from material having some
elasticity characteristics, and more preferably from a material selected
from a group consisting of natural fibers or manmade plastic fibers.
Natural fibers could include cotton, linen and silk. Plastic fibers could
include nylon, dacron and rayon. Preferably the degree of elasticity
should be at least to a degree such that the material would begin to
stretch before the pulling force exceeded a predetermined amount. That
amount would depend on the stage of development of the fetus, as well as
other known factors. The degree of elasticity is preferably set so the
pulling force is less than that which would harm the fetus. Member 5 is
also preferably pliable so that it can be shaped and easily moved in
position about head 4. In another preferred embodiment the material will
be constructed from a mesh material, the size of the mesh would preferably
be sufficiently small enough to reduce chances of non-beneficial oral
ingestion of toxic meconium by the fetus. In still another preferred
embodiment the fabrics would be sterilized and lubricated with K-Y jelly
to reduce or prevent the fabric from absorbing the natural lubricants
within the womb. K-Y jelly is a brand name for a product sold by Johnson &
Johnson.
The member 5, which in one embodiment will be constructed of the
aforementioned mesh material, will comprise an angular mesh as seen at 5
of FIG. 4. Once the member 5 has been placed in position over the head of
the infant, this angular mesh will impart a uniform distribution of
forces, as in the manner of the Chinese handcuff, as the member 5 is
pulled in a linear direction, with respect to the passageway 6. In other
words, all areas of the infants head which are in contact with the mesh of
member 5 will have exerted against it a gripping axial force created by
the diminishment of size of the angular mesh secondary to traction; thus,
as the member 5 is pulled, all of the pulling force will be distributed
across the area which is in contact with the infant's head and axial
gripping of the child's head has been initiated. Also, in one embodiment,
the angular mesh is constructed of a synthetic or natural fiber. The fiber
can be round or elliptical in cross-section and be mono-filament or
bi-filament fibers.
In the embodiment shown in FIG. 2, collar 7 is constructed of an elastic
material which can be stretched to fit about head 4 and then will contract
to an extent to fit loosely about the neck area 10 of the fetus 1. In this
manner collar 7 will not choke the fetus 1, but also will not easily slip
over the head 4 when the physician pulls on end 11 of member 5 during the
delivery process as described below.
In another embodiment as shown in FIG. 3, collar 7 is constructed from a
pliable material wherein one edge section 12 has been folded over and
stitched to itself to form a drawstring pocket 13 in which drawstring 14
has been placed. When drawstring 14 is pulled opening 15 is restricted.
The other edge section 16 of collar 7 is stitched or otherwise connected
to member 5 along line 17.
In a third embodiment as shown in FIG. 4, collar 7 is constructed of a
strip 18 of pliable material having one section 19 stitched or otherwise
connected substantially about the perimeter of end 8, and having another
section 20 that can extend over a portion of the first section 19. Strips
21 of Velcro or similar material are attached to side 22 of section 19 in
a position to be alignable with at least a portion of the strips 23 of
Velcro or similar material attached to side 24 of section 20. Velcro is a
registered trademark of VELCRO INDUSTRIES, B.V. (NETHERLANDS CORPORATION)
identifying hook and loop fastener systems. The size of opening 15 can be
adjusted by changing the alignment of the strips 21 and 23. Opening size
is then maintained by contacting the overlapping sections of the strips to
one another.
In the embodiment as illustrated in FIGS. 2-4, collar 7 is provided with
one or more pockets, preferably two or more, formed by a piece 25 of
fabric that is attached on three sides to collar 7 to form an opening 26
facing toward member 5. The opening 26 will be large enough so that one
end of wand 27 can be inserted through the opening. Wand 27 is preferably
constructed from a flexible material, such as plastic, that would will
allow it to conform to the shape of the fetus' head, yet rigid enough to
allow it to be used to push collar 7 around the fetus' head when
positioning device 3.
Referring to FIG. 5, another embodiment of the present invention is
depicted. The elongated member 100 has a first end 102 and a second end
104, with a passageway 106 defined therein. The member is constructed of
the angular mesh material 108, as previously described. The collar means
110 is constructed of pliable material and is similar in design to the
collar 7 in that collar 110 is connected to the first end 102 of the
elongated member 100, so that the first end 102 encircles the infant's
neck. The collar means 110 will have an elastic band 111, as seen in FIG.
8, sewn into the hem of the collar and sized to rest at a diameter
sufficient to preclude carotid or larynx compression and to expand to a
diameter sufficient to permit application over the largest portion of the
fetal skull.
The collar means 110 will also contain a widened below chin segment 112,
which is also illustrated in FIG. 7. The chin segment 112 is generally a
protuberance on the collar means 110 which is adapted so that the infants
chin can be abutted adjacent thereto when the member 100 is being pulled
during childbirth. The collar means 110 will also comprise pocket means
114, similar to the aforementioned pockets 25, for receiving the wand or
wands 116, which is also referred to as the insertion means 116, as seen
in FIG. 6A.
The elongated member 100 can also posteriorly contain a linear mesh segment
118 which is attached to the first end 102 and is best seen in FIG. 7. The
linear mesh segment 114 will exhibit enhanced tensile properties so that
during delivery, the fetus' skull may be tilted in a vertical plane
relative to the sternum by applying traction to the linear mesh segment
114 to achieve increased flexion.
As seen in FIG. 19, the second end 104 can contain an access means 119,
which is a rigid, plastic ring of an internal diameter equal to or
slightly larger than the internal diameter of the passageway 106. The
access means will permit the immediate access through the cylinder to the
fetal skull for usual and necessary obstetrical procedures.
Referring to FIG. 6A and 6B, one embodiment of the insertion means will now
be described. The insertion means 116, or wand 27 as referred to earlier
in this application, is provided for inserting the collar means 110 over
the infant's head. The insertion means, as seen in FIGS. 6A and 6B, will
have a first and second member 120, and 122. The second member 122 will
overlay the first member 120 in the slotted groove 124 of member 120.
Member 120 will have a first end wedge section 126, with said wedge section
having a first surface 128 which extends to angled shoulders 130 and 132.
Shoulder 130 terminates at the back surface 134 and shoulder 132
terminates at the back surface 136. Both surfaces 134 and 136 extend to
the elongated segment 138, with the elongated segment extending to the
perpendicular segment 140, also known as the thumb tab.
The elongated segment 138 is slidably disposed within the groove 124 of the
first member 120 so that the segment may be moved outward or inward in a
telescopic fashion. Thus, if the operator is holding first member 120, and
exerts a force on the thumb tab 140, the second member will be moved away
relative to the first member 120.
First member 120 will have a first and second end 142, 144, with the first
end containing ridges 146 and 148. Ridges 146 and 148 will be sized so
that as the ridges are placed within the pockets 112, the ridges 146 and
148 engage the pocket with some mechanical restriction. First member will
also have defined thereon graduations 150, marked in centimeters.
Referring now to FIG. 7, the insertion means 116 have been inserted into
the pocket means 114 before the apparatus is attached to the fetus. In
this position, the ridges 148 and 146 are fitted into pocket 112 with some
mechanical restriction so that the ridges do not easily slip out of the
pockets during positioning of the apparatus. In FIG. 8, the invention is
attached to the infant's head. Hence, utilizing the insertion means 116,
it can be seen that the collar means 110 has been positioned around the
infants neck and the chin segment 112 has been placed beneath the mandible
area. The elastic 111 of the collar means 110 will, therefore, cause the
collar to surround the neck so that the elongated member 100 does not slip
off.
After the proper position has been obtained about the fetus, the insertion
means 116 can be removed from the pockets 114 as seen in FIG. 8. This will
entail the physician having to hold member 120, then begin pushing second
member 122 by pushing on the thumb tab 140 in a direction such that
surface 128 is constrained against the pocket means 114. This will cause
the wedge member 126 to continue to act against the pocket member 112 and
thereby cause the collar means to move, but because the member 120 is
being held stationary, the ridges 146 and 148 will be slipped out of the
pocket 112. Conversely, the physician can hold the thumb tab 140
stationary, and pull on the first member 120 thereby disengaging the
ridges 146 and 148 from the pockets.
FIG. 9 shows a cut-away view of the infant in the birth canal after
placement of the collar means 110 in the position for removal of the
infant. As can be seen from this view, the chin segment 112 is centered
below the mandible. As noted earlier, as the elongated member 100 is
pulled by the operator of the device, which in most cases is a medical
doctor, the axial gripping forces of the mesh will distribute the pulling
forces to all areas of the mesh which have been expanded by the infant's
head.
Referring to FIG. 10A and 10B, handle means 152 is shown which may be used
for holding and placing the aforementioned insertion means 116 into the
pocket means 114. The handle means comprises generally a tubular cylinder
154 which has an internal diameter roughly the size of the passageway 106.
The cylinder 154 will contain a plurality of slots 156 which will have
fitted therein the first member 120 of the insertion means 116. In
particular, second end 122 will be inserted into one of the slots 156. In
the preferred embodiment of the handle means 152, there will be three
slots, such that three wands 116 can be attached to the handle means 152.
As seen in FIG. 11, the handle means 152 has been attached to the elongated
member 100 by placing the second end 144 of wands 116 into the slots 156,
and by having the wedge section 126 of the second member 122 engaged with
the pocket means 114. As seen in FIG. 11, the apparatus, which includes
the handle means 152 containing the insertion means 116 is now available
for placement over the fetal head.
In order to remove the handle means 152, disengagement of the wands 116
with the pocket means is accomplished as previously discussed. FIG. 12
shows the position of the handle means 152 after the apparatus has been
placed over the head of the fetus and removal of the insertion means has
begun. FIG. 12 also shows the elastic band 111 of the collar means 110.
Turning to FIG. 13, the elongated member 100, along with the collar means
110 and chin segment 112, is shown after the insertion means 116 have been
removed. As can be seen, the angular mesh has been expanded by the head of
the infant so that the previously described axial gripping force will be
applied once the doctor has exerted a lateral pull on member 100 to assist
in the removal of the infant from the birth canal.
Referring now to FIGS. 14 and 15, another embodiment of the present
invention will be discussed. The insertion means 116 consist of a single,
flat, one-piece flexible wand with a first end 158 and second end 160. In
the embodiments of FIGS. 14 and 15, three flexible wands will be employed,
162, 164 and 166. The single wands, 162, 164 and 166, will have already
been placed within the pockets 114 which are disposed about the collar
means 110 before the apparatus is placed over the fetal head.
FIG. 14B shows an enlarged view of the wand 166, with graduations in
centimeters. The first end 158 will fit with some mechanical constriction
into the pocket means 114, as can also be seen in FIG. 15. Thus, as shown
in FIG. 15, the wands 162, 164, and 166 are positioned within the pockets
114 of collar 110. The first end 158 of wand 164 is illustrated as being
pulled away from the collar means 110. In other words, the wand 164 has
been pushed downward into the proper below mandible position by
manipulating the wand downward. Next, wands 162 and 166 are manipulated,
and once the proper position is reached, the wands 162, 164, and 166 can
be removed by pulling the wands away from the pockets, which is shown by
the relative position of wand 164 to the collar means 110.
FIG. 16 depicts another embodiment of the insertion means 116. In this
embodiment, three elongated, flat, elongated wands 168, 170 and 172. Each
of these wands will have a first end 174 and a second end 176, with the
first end 174 of the wands 168, 170 and 172 being joined to a
perpendicular member 178 which forms a collar 180, as seen in FIG. 17. In
this embodiment, the perpendicular member 178 will be fitted into a folded
latex hem of the woven mesh cylinder. The internal diameter of collar 180
at rest will be sufficient to preclude compression of the carotids or of
the larynx and with an expansion diameter sufficient to permit application
over the fetal skull. FIG. 18 shows the member 178 in place, as the member
178 has been folded to form a collar 180.
Referring to FIG. 20, the preferred embodiment of this invention will now
be described. The device for assisting delivery, seen generally at 200,
comprises a cylindrical member 202 having a tubular passageway, the
cylindrical member including a first end 204 and a second end 206. The
cylindrical member 202 will be formed of an angular mesh material 208,
also known as a braid, that is seen in FIG. 22 and will be more fully set
out later in this application.
The angular mesh material 208 is formed similar to the other angular mesh
material of the other disclosed embodiments so that as the cylindrical
member 202 is pulled by the operator of the device, the axial gripping
forces of the mesh will distribute the pulling forces to all areas of the
mesh which have been expanded by the infant's head.
The cylindrical member 202 will have a first outer layer 210 and a second
inner layer 212. As depicted in FIG. 20, one way to obtain this first 210
and second 212 layered cylindrical member 202 is to extrude a continuous
cylindrical member, and then, fold the cylindrical member so that a first
outer layer 210 and a second inner layer 212 is formed.
Once the cylindrical member has been folded over, a first end 204 is
formed. The collar means 214 for encircling the neck of the fetus is
generally located within the first end 204. The collar means 214 will be
an enveloping structure such as a nylon sheath member that will contain a
drawstring 216. The drawstring 216 will have a first end 218 and a second
end 220 and is held together by fastener 221. As can be seen in FIG. 20,
the drawstring is looped around the end portion 204 within the collar
means 214 of the cylindrical member 202 such that the looped portion of
the drawstring 216 constitutes part of the collar means 214. Thus, as the
drawstring 216 is pulled, generally from the fastener 221, the looped
portion of the drawstring 216 will decrease in size, which in turn will
cause the diameter of the collar means 214 to decrease.
A sheath 222 which is positioned between the outer layer 212 and the inner
layer 212 is also provided. The drawstring 216 can be held within the
sheath 222 as seen in FIG. 20. A second sheath positioned approximately
180 degrees from the first sheath 222 may also be provided but has not
been shown. The sheath is generally an elongated nylon pocket member that
is adapted to receive the insertion wand member 250 as seen in FIG. 21,
and as will be described in further detail.
The sheath 222 will be attached at two different points to the device 200.
First, the sheath 222 will be attached to the first end 204 at 226 of the
cylindrical member. Second, the sheath 222 will be attached to the
cylindrical member at point 228. The point of attachment 228 is generally
the point wherein the cylindrical mesh material member is no longer woven,
which is referred to as the beginning of the pigtails. Further, at each
attached point 226 and 228, the sheaths 222 are attached only to one wall
of the device 200. This prevents interruption of inability to peel and
compress in the event the device will need to be removed before delivery
of the fetus.
As seen in FIG. 20, the point wherein the cylindrical member is no longer
woven then branches out until three different pigtail branches 230, 232,
234. These branches 230, 232, and 234 will then be joined together at
handle means 236. The traction handle means 236 are used to hold the
different branches of material together, as well as being used as a
location for the operator of the device, generally a medical doctor, to
grab hold and exert a lateral pulling force thereon. As seen, the handle
means 236 is an oval shaped member, but of course may take on different
shapes.
Removal ring means 238 are also provided. The ring means 238 are for quick
removal of the device if necessary. The ring means 238 are attached only
to the outer layer 210. The ring means 238 functions by allowing pulling
to be done only on the outer wall 210 of the cylinder 202 on one quadrant.
Pulling on the ring means 238 by the operator causes the cylinder to peel
off of the fetus' head by destroying the axial gripping of the angular
mesh 208. The ring means 238 must be positioned on the cylinder 202 such
that they remain outside of the introitus for easy access after
application of the device 200.
Referring now to FIG. 21, the cephalic curve insertion wand member 250 of
the preferred embodiment is illustrated. The insertion wand member 250 has
a first surface 252 that in turn leads to a first angled surface 254, with
angled surface 254 concluding at second angled surface 256. The second
angled surface 256 terminates at end 258. The end 258 can be flattened
(not shown) to prevent protrusion through the webbing during application.
Extending from the end 258 is the curved surface 260 which generally
approximates the cephalic curve of the fetus. The curved surface extends
to the surface 262, with surface 262 concluding at the wand insertion
member handle means 264. Wand end 258 must be thin enough to be pliable,
yet thick enough to retain longitudinal strength.
Referring now to FIG. 22, the angular mesh braid material 208 will now be
described. Generally, the angular mesh braid iteration 208 will be made up
of two alternating materials. A flat shoe string material 270 will be
interwoven with a series of multiple monofilament strands 272, such as
fishing line. This composition gives body to the device 200, enhances
axial gripping and adds strength to the angular mesh material 208. In the
preferred embodiment the number of monofilament strands used in series is
six. It should be noted that the portion of angular mesh material 208
depicted in FIG. 22 pertains to both the outer layer 210 or inner layer
212.
Referring to FIG. 25, the preferred embodiment is depicted wherein a shrink
wrap means 270 is included. The shrink wrap means 270 is generally a
cylindrical piece of clear plastic which is disposed about the end 204.
The shrink wrap means 270 is included in order to constrict the diameter
of the first end 204 so that the device 200 can be inserted to a
sufficient depth, and then once the appropriate depth is reached, which
generally is about one-half inch into the vaginal introitus, but may vary
depending on the characteristics of the mother, the tabs 272, 274 will be
pulled by the operator of the device and the device will be separated
along the perforated line 276. Next, the shrink wrap means is then removed
and discarded. Since the end 204 has been inserted to a sufficient depth,
the device 200 is in place to begin positioning the collar means 214 about
the head of the fetus as will be more fully set out in the operation
portion. FIG. 25 also depicts the insertion wand member 250 which has been
inserted into the sheath member 222, as well as the draw string 216.
Still another embodiment of the invention is depicted in figs. 26 and 27
which depicts the device being utilized for breech births. FIG. 26
illustrates the device being inserted and positioned for the breech
delivery. FIG. 27 represents the device being used to deliver the fetus.
In operation, the device 3, as shown in the embodiments of FIGS. 1-4, is
first positioned on the top of the fetus' head 4 with the wands 27 fitted
into pockets 25. The wands 27 are then maneuvered by pushing the ends of
each wand 27 against the inside walls of their respective pocket 25 until
the device is slipped over the fetus' head. When the collar 7 extends
posterior to the head 4 the physician then adjusts collar 7 so that it
fits loosely about neck area 10, but is restricted so as not to easily
slip over the head 4. The physician then grabs the end 11 and applies a
pulling force which will cause the collar 7 to exert an equalized and
evenly distributed resistance to the pulling force sufficient to initiate
axial uniform gripping of the fetal skull in the manner of the Chinese
Handcuff. This pulling force will assist the mother in natural childbirth.
Once the fetus has been removed, the physician then removes device 3 from
the head 4. The device is then preferably discarded and not reused.
As regards the method of assisting the delivery of an infant during
childbirth utilizing the elongated member of FIG. 5 and the insertion
means of FIGS. 14A and B, first, the insertion means, which comprises of
members 162, 164, and 166, are fitted into the pocket means 114. Then, the
collar means 110 is guided over the infants head by applying force to the
insertion means until the collar is anteriorly below chin depth and
posteriorly below the smallest portion of fetal skull as shown in FIG. 13.
Next, the device is pulled from the second end 104 of the elongated member
100, and the pulling force exerted on the second end 104 will be uniformly
distributed about the fetus' skull due to the axial gripping of the mesh.
Continuous or intermittent pulling, as needed, on the second end 104 will
result in assistance in delivery of the infant.
The delivery of the child may also be accomplished with any of the other
embodiments heretofore disclosed. For instance, the insertion means 116
may be employed, inste | | |
